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Recall Observatory FDA recall evidence

Device product

Respirator Crash Cart Kit

Z-2466-2020

May 19, 2020

Class II

Product summary

Firm
ROi CPS LLC
Event
Event 85736
Status
Terminated
Classification
Class II
Quantity
200 kits
Official record key
device-enforcement:Z-2466-2020

Official wording

Reason: Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are labeled with an expiration date that is later than that of the soonest kit component to expire in the kits.

Code information: Item #: 830066; Lot #: 77127, 74813 and 63168 Expiration date per lot: Lot: 77127, Exp date: 1/31/2021 Lot: 74813, Exp date: 8/30/2021 Lot: 63168, Exp date: 1/30/2021

Distribution pattern: Domestic distribution only to: MO and LA.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    labeling error